Prospective Study of TW in Treatment of IgAN With Asymptomatic Abnormal Urinalysis

Not Applicable

Terminated

• Conditions: IgA Nephropathy
• Interventions: Drug: tripterygium wilfordii (TW)

• Registration Number: NCT00885547
• Lead Sponsor: Nanjing University School of Medicine

Brief Summary

The purpose of this study is to:

1. To evaluate the latest effects of TW for IgA nephropathy (IgAN) with asymptomatic abnormal urinalysis.

2. To evaluate the safety and tolerability of TW.

Detailed Description

Patients who fit the inclusion criteria will be randomly divided into three groups: TW group (TW at dosage of 90 mg/d), ARB group (the control group, valsartan at dosage of 160 mg/d) and combined treatment group (TW at dosage of 60 mg/d and valsartan at dosage of 80 mg/d).

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-04-20
• Study First Submitted QC: 2009-04-20
• Study First Posted: 2009-04-22
• Primary Completion: 2011-04
• Study Completion: 2011-05
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-31
• Last Update Posted: 2015-04-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

1. 18-60 years old but no requirement for gender
2. All well fit the Diagnostic Criteria for Primary IgAN and IgAN with asymptomatic abnormal urinalysis
3. Informed consent is obtained from each research subject who agrees to conduct a periodic follow-up according to the research arrangement

Exclusion Criteria

1. Secondary IgA nephropathy, such as Henoch-Schönlein purpura nephritis, Lupus nephritis and so on
2. Some secondary kidney diseases like diabetic nephropathy or other systemic diseases which may effect the pathologic and physiological function of kidney like hypertension and arteriosclerosis
3. Severe infection
4. Abnormality of liver function with glutamic pyruvic transaminase (GPT) or glutamic-oxal(o)acetic transaminase (GOT) more than twice upper limit of normal
5. Women during pregnancy and lactation
6. Patients need to procreation lately
7. Patients treated with TW or ARB within 4 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
immunosuppressor	tripterygium wilfordii (TW)	-

Primary Outcome Measures

Name	Time	Method
The percentage got to complete remission (CR) of TW group, the combined treatment group, and the control group after the 3, 6 months treatment.	12 months

Secondary Outcome Measures

Name	Time	Method
The percentage of total effect of the 3 groups and adverse event within the follow-up periods.	12 months